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Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation

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ClinicalTrials.gov Identifier: NCT04837313
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Guangzhou First People's Hospital

Study Description
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Brief Summary:

Parkinson's disease(PD) may cause the autonomic nervous system's improper functioning, which is responsible for regulating the intestinal tract movement. A certain degree of degeneration of digestive system function can cause PD patients to constipation symptoms. Studies have shown that up to 63 percent of people with Parkinson's disease experience constipation. What is more, medications for PD, including levodopa and dopamine agonist, can also cause constipation. In recent years, an increasing number of studies have been conducted to investigate gut microflora and their influence on the central nervous system. Furthermore, some studies of Parkinson's disease have confirmed that gut microflora plays a vital role in the occurrence and development of Parkinson's disease.

The purpose of this study is to evaluate the efficacy and safety of fecal microbiota transplantation in the treatment of constipation symptoms in patients with Parkinson's disease receiving a steady dose of levodopa. We will also analyze intestinal flora diversity in patients with Parkinson's disease with constipation. The investigation of the gut microbiome may emerge as a new therapeutic measure to treat constipation associate with Parkinson's disease.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : October 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Parkinson's Disease with Constipation
Fecal microbiota transplantation will be performed.
 Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation


Outcome Measures
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Primary Outcome Measures :
  1. The Efficacy of FMT in patients with constipation will be assessed by the change of The Gastrointestinal Symptom Rating Scale (GSRS) and Wexner Constipation Score. [ Time Frame: 6 months ]

    The data will be collected in several time points from baseline to 6 months after FMT. Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom.

    Wexner Constipation Scoring system is a scale to evaluate the severity of constipation. These factors included frequency of bowel movements, painful evacuation, incomplete evacuation, abdominal pain, length of time per attempt, assistance for evacuation, unsuccessful attempts for evacuation per 24 hours, and duration of constipation, with 0 indicating normal and 30 indicating severe constipation.



Secondary Outcome Measures :
  1. The improvement of clinical symptoms in patients with Parkinson's Disease will be assessed by the change of several scales of Parkinson's Disease. [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 18-75 years of age
  • Signed informed consent form
  • Clinical diagnosis of Parkinson's disease (according to 2016 edition of Chinese Parkinson's disease diagnostic criteria)
  • Parkinson's disease duration of 1 year or more
  • Hoehn & Yahr stage 1-4 (including)
  • Patients have following 2 or more symptoms, which appear for at least 6 months and exist in recent 3 months: A. at least 25% of defecation feel strenuous; B. At least 25% of defecation was not massive or hard; C. at least 25% of defecation had incomplete feeling; D. at least 25% of defecation had anorectal obstruction; E. at least 25% of defecation needed manual assistance; F. defecation less than 3 times a week, with or without abdominal pain
  • Patients are taking oral L-dopa (with or without Benserazide, carbidopa, and O-methyltransferase inhibitors) at least 4 weeks, and be able to tolerate a steady dose of dopamine agonists, monoamine oxidase B inhibitors, anticholinergics, and / or adamantine.
  • Patients are taking stable dosage of anti-PD drugs, antidepressant drugs and antipsychotics for more than 1 month.
  • Be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.
  • Be able to receive follow-up visit, follow-up examination and specimen collection on time

Exclusion Criteria:

  • Patients with Parkinson's syndrome and Parkinsonism plus syndrome
  • History of cerebrovascular accident, brain injury, epilepsy and other brain injury
  • The "opening" stage was Hoehn & Yahr 5
  • Patient received neurosurgical intervention or stereotactic brain surgery for Parkinson's disease
  • Patients with organic lesions of digestive tract
  • Patients had major abdominal surgery
  • History of infectious diarrhea and took antibiotics in recent 2 weeks
  • Patients infected with Clostridium difficile and other pathogens
  • Patients with HIV or compromised immune system (such as congenital immunodeficiency or currently taking immunosuppressive drugs)
  • Patients with uncontrollable basic diseases of digestive system
  • Patients could not fully understand and sign the informed consent form
  • Patients who were not considered suitable for inclusion in the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837313


Contacts
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Contact: Yongjian Zhou, MM 86-13503060150 eyzhouyongjian@scut.edu.cn
Contact: Hongli Huang, MM 86-13631316718 honglisums@126.com

Locations
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China, Guangdong
Guangzhou First People's Hospital Recruiting
Guangzhou, Guangdong, China, 510180
Contact: Yongjian Zhou, MM    86-13503060150    eyzhouyongjian@scut.edu.cn   
Contact: Hongli Huang, MM    86-13631316718    honglisums@126.com   
Sub-Investigator: Yandi Liu, MM         
Sponsors and Collaborators
Guangzhou First People's Hospital
Investigators
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Principal Investigator: Hongli Huang, MM Guangzhou First People's Hospital
More Information
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Publications:

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Responsible Party: Guangzhou First People's Hospital
ClinicalTrials.gov Identifier: NCT04837313    
Other Study ID Numbers: K-2020-107-02
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Constipation
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Signs and Symptoms, Digestive